A Study of Ocrelizumab in Participants With Follicular Non-Hodgkin's Lymphoma (NHL)

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Ocrelizumab

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Follicular NHL
Documented history of response, or stable disease more than 6 months in duration, to a rituximab-containing regimen that was the last treatment before enrollment in the study
No evidence of hepatitis B or C

Exclusion Criteria:

Prior monoclonal antibody therapy other than rituximab, anti-cancer vaccine, or radioimmunotherapy for cancer
History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
Major nondiagnostic surgery within 4 weeks of Screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort A: Ocrelizumab 200 mg/m^2

Cohort B: Ocrelizumab 375 mg/m^2

Cohort C: Ocrelizumab 375/750 mg/m^2

Arm Description

Participants will receive a total of 8 infusions of ocrelizumab 200 milligram per square meter (mg/m^2) given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Participants will receive a total of 8 infusions of ocrelizumab 375 mg/m^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Participants will receive first infusion of ocrelizumab 375 mg/m^2 followed by 7 infusions of 750 mg/m^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Number of Participants With Dose-limiting Toxicity (DLT)

Secondary Outcome Measures

Progression-free Survival According to the International Workshop to Standardize Response Criteria for NHL

Event-free Survival According to the International Workshop to Standardize Response Criteria for NHL

Area Under the Plasma Concentration-Time Curve From Time 0 to Day 28 (AUC0-28) of Ocrelizumab

Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity AUC(0-inf) of Ocrelizumab

Percentage of Participants With Overall Response According to the International Workshop to Standardize Response Criteria for NHL

Maximum Plasma Concentration (Cmax) of Ocrelizumab

Systemic Clearance (CL) of Ocrelizumab

Steady State Volume of Distribution (Vss) of Ocrelizumab

Terminal Elimination Half-Life (t1/2) of Ocrelizumab

Number of Participants With Peripheral Blood B-cell Depletion

Number of Participants With Peripheral Blood B-cell Recovery

Full Information

NCT ID

NCT02723071

First Posted

March 24, 2016

Last Updated

March 24, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02723071

Brief Title

A Study of Ocrelizumab in Participants With Follicular Non-Hodgkin's Lymphoma (NHL)

Official Title

An Open-label, Multicentre, Dose-escalating Phase I/II Trial of 3-weekly Ocrelizumab in Patients With Follicular Non-Hodgkin's Lymphoma (NHL)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A: Ocrelizumab 200 mg/m^2

Arm Type

Experimental

Arm Description

Participants will receive a total of 8 infusions of ocrelizumab 200 milligram per square meter (mg/m^2) given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Arm Title

Cohort B: Ocrelizumab 375 mg/m^2

Arm Type

Experimental

Arm Description

Participants will receive a total of 8 infusions of ocrelizumab 375 mg/m^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Arm Title

Cohort C: Ocrelizumab 375/750 mg/m^2

Arm Type

Experimental

Arm Description

Participants will receive first infusion of ocrelizumab 375 mg/m^2 followed by 7 infusions of 750 mg/m^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Intervention Type

Drug

Intervention Name(s)

Ocrelizumab

Other Intervention Name(s)

RO4964913

Intervention Description

Participants will receive a total of 8 intravenous (IV) infusions of ocrelizumab given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Primary Outcome Measure Information:

Title

Number of Participants With Dose-limiting Toxicity (DLT)

Time Frame

first cycle (3-week cycle) of Cohort A, Cohort B, and Cohort C

Secondary Outcome Measure Information:

Title

Progression-free Survival According to the International Workshop to Standardize Response Criteria for NHL

Time Frame

Day 1, after 4 and 8 cycles of therapy (12 and 24 weeks after study entry) until disease progression/relapse, or death, whichever occurred first (overall up to approximately 2.75 years)

Title

Event-free Survival According to the International Workshop to Standardize Response Criteria for NHL

Time Frame

Day 1, after 4 and 8 cycles of therapy (12 and 24 weeks after study entry) until disease progression/relapse, or death, whichever occurred first (overall up to approximately 2.75 years)

Title

Area Under the Plasma Concentration-Time Curve From Time 0 to Day 28 (AUC0-28) of Ocrelizumab

Time Frame

Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539

Title

Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity AUC(0-inf) of Ocrelizumab

Time Frame

Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539

Title

Percentage of Participants With Overall Response According to the International Workshop to Standardize Response Criteria for NHL

Time Frame

Day 1, after 4 and 8 cycles of therapy (12 and 24 weeks after study entry) until disease progression/relapse, or death, whichever occurred first (overall up to approximately 2.75 years)

Title

Maximum Plasma Concentration (Cmax) of Ocrelizumab

Time Frame

Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539

Title

Systemic Clearance (CL) of Ocrelizumab

Time Frame

Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539

Title

Steady State Volume of Distribution (Vss) of Ocrelizumab

Time Frame

Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539

Title

Terminal Elimination Half-Life (t1/2) of Ocrelizumab

Time Frame

Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539

Title

Number of Participants With Peripheral Blood B-cell Depletion

Time Frame

Week 24, 28 days following the final infusion (Day 176), 9, 18, 24, and 30 months after study entry or until B cell recovery, whichever occurred first (up to approximately 2.75 years)

Title

Number of Participants With Peripheral Blood B-cell Recovery

Time Frame

Week 24, 28 days following the final infusion (Day 176), 9, 18, 24, and 30 months after study entry or until B cell recovery, whichever occurred first (up to approximately 2.75 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Follicular NHL Documented history of response, or stable disease more than 6 months in duration, to a rituximab-containing regimen that was the last treatment before enrollment in the study No evidence of hepatitis B or C Exclusion Criteria: Prior monoclonal antibody therapy other than rituximab, anti-cancer vaccine, or radioimmunotherapy for cancer History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products Major nondiagnostic surgery within 4 weeks of Screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Melbourne

ZIP/Postal Code

3002

Country

Australia

City

Perth

ZIP/Postal Code

6000

Country

Australia

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1C4

Country

Canada

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

City

Creteil

ZIP/Postal Code

94010

Country

France

City

Lille

ZIP/Postal Code

59037

Country

France

City

Nantes

ZIP/Postal Code

44093

Country

France

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

City

Rennes

ZIP/Postal Code

35033

Country

France

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

City

Roma

ZIP/Postal Code

00161

Country

Italy

City

Torino

ZIP/Postal Code

10126

Country

Italy

City

Huddinge

ZIP/Postal Code

14186

Country

Sweden

City

Lund

ZIP/Postal Code

22185

Country

Sweden

City

Malmoe

ZIP/Postal Code

20502

Country

Sweden

City

Umea

ZIP/Postal Code

90185

Country

Sweden

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

City

Geneve

ZIP/Postal Code

1211

Country

Switzerland

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Non-Hodgkin's Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial